CHSR DEPARTMENT OF DEFENSE PHARMACEUTICAL SUPPLY CHAIN PORTFOLIO

The CHSR has developed a portfolio of projects related to the national security of the Department of Defense (DoD) Pharmaceutical Supply Chain. These include both “Assessing the Security and Quality of the U.S. Military Health System Pharmaceutical Supply Chain: A Pilot Study (PhaSQ)” and “Domestic Production of Pharmaceutical Products for the Military Health System (DP3).” 

 

ASSESSING THE SECURITY AND QUALITY OF THE U.S. MILITARY HEALTH SYSTEM PHARMACEUTICAL SUPPLY CHAIN: A PILOT STUDY (PhaSQ)

 

The Nation and military readiness are impacted by the quality, safety, and availability of pharmaceutical products. The PhaSQ study benefits the entire Nation by identifying and potentially mitigating the negative impacts of ineffective, impure, or unavailable pharmaceuticals. This study will assess the quality, safety, and availability of pharmaceuticals which are critical to the U.S. healthcare system as well as formally develop, apply, and test a decision-making tool relevant to the public and private health sectors. A lack of resilience and lack of transparency regarding quality in the supply chain, and the reliance on other countries for the necessary ingredients to manufacture crucial drugs, are known risks to national security. Results from this study are anticipated to inform policy making regarding sourcing and distribution of high-quality essential drug products.

 

Strategic objectives of this project include:

  1. Environmental Scan of the Department of Defense pharmaceutical supply chain
  2. Comparison of Essential Medicines Lists between US DoD, FDA, and DHHS and the WHO
  3. Evaluation of pharmaceutical drug products and application of the Red, Yellow, Green Scoring Tool
  4. Acceptability Study of the proposed Red, Yellow, Green Scoring Tool 

 

DOMESTIC PRODUCTION OF PHARMACEUTICAL PRODUCTS FOR THE MILITARY HEALTH SYSTEM

 

In addition to quality and shortage concerns, the dependence of the U.S. market on non-domestically produced Active Pharmaceutical Ingredient (API) (~85% manufactured outside U.S.) and Finished Dosage Form (FDF) (~60% manufactured outside U.S.) creates geo-political vulnerabilities. Significant risks to the supply chain are present given the possible impact of multiple geo-political dynamics such as international trade negotiations, climate and weather-related disasters, natural calamities, outbreaks of diseases such as COVID-19, and military conflicts. The FY 2024 Domestic Production of Pharmaceutical Products for the Military Health System (DP3) is designed to support the DoD, Defense Logistics Agency, and the Nation across four broad areas of importance to onshoring and near-shoring Active Pharmaceutical Ingredients by:

 

  1. Creating quality and supply chain resilience ratings for chosen drugs; and, to analyze the key drivers of drug quality and supply chain resilience, including factors at the firm (e.g., headquarter location), supply chain (e.g., manufacturing facility locations; contract manufacturing), market (e.g., number of competitors) and drug (e.g., sterile injectable).

  2. Exploring “make, buy, and invest” strategic actions to strengthen the U.S. pharmaceutical supply chain by identifying key drugs and markets that could benefit the most, assess the primary challenges and opportunities, and outline essential steps for implementation. By advancing our understanding of the challenges and opportunities associated with make-buy-invest strategies, the project aims to develop solutions to drug shortages and enhance the resilience of the US pharmaceutical supply chain against shocks from pandemics, geopolitical conflicts, natural disasters, and others.

  3. Addressing international and national supply chain fragility and future shortages through a lens of domestic and international policy and measure the potential risk from off-shore APIs on operational readiness and the Military Health System population.

  4. Critically synthesizing and updating the literature on potential API and KSM production in the United States. 

     

 

The CHSR Pharmaceutical Supply Chain Portfolio projects are being conducted in collaboration with our partners:

CHSR Pharmaceutical Supply Chain logos